Standard work schedule (Mon-Fri). Must be able to lift 40 lbs. without assistance. Adherence to GMP safety standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair. Cold Room/Freezers -22°F/-6°C. Laboratory setting. Some PPE required (safety glasses, gowning, gloves, lab coat, ear plugs).
Warehouse Position Summary:
Manufacture raw and sterile liquids for use in the pharmaceutical and biotech industry following established protocols and instructions. The products are scientific in nature and this role suits a team member with an interest in science and manufacturing.
Key Responsibilities
- Complete day-to-day production activities in conformance with specifications, SOPs, and cGMP/ISO principles.
- Complete raw processing and sterile/cleanroom operations including setup, dispensing, monitoring, sampling and testing with limited supervision.
- Complete sterile serum filtration operations: setup, pooling, filtering, and integrity testing.
- Complete Batch Manufacturing Records (BMRs), ensuring timely, accurate, legible, and correct traceability.
- Contribute to revision, issue, and control of manufacturing documentation on site, including batch manufacturing records, SOPs and forms.
- Communicate production issues and potential solutions to Production Supervisor or Team Leader as they arise.
- Balance multiple tasks and prioritize critical tasks.
- Act as Subject Matter Authority within the team, using experience and logic to solve moderate to complex problems and assist others.
- Participate in PPI activities (Kaizens and JDIs) as appropriate and use continuous improvement methodologies.
- Participate in EHS system by adhering to SafeWork NSW legislation, company policies and procedures, and reporting hazards.
- Perform other tasks as required to contribute to productive operation of the team and business.
Minimum Requirements / Qualifications
- Experience in cGMP manufacturing and/or analytical laboratories (preferred).
- Science-related qualification is desirable.
- Good mechanical competence.
Skills
- Interpersonal: communicates openly, comfortably and professionally with diverse groups of people.
- Teamwork/Cooperation: builds partnerships and works collaboratively with others to meet shared objectives.
- Process Improvement: embraces continuous improvement using company tools.
- Problem Solving/Decision Making: seeks appropriate data and uses problem solving tools before making decisions.
- Growth Focus: works to meet business goals set by management.
Personal Qualities
- Proactive, anticipates needs.
- Motivated to get the job done and motivates others.
- Takes ownership.
- Demonstrates flexibility.
- Ability to multi-task.
Required to stand for long periods of time. Must be able to work safely with chemicals or hazardous materials. Must be flexible around hours, including Tuesday to Saturday shifts, and work overtime if needed.
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